Appeal rejected
Four UK charities have joined forces to urgently campaign for a potentially sight-saving drug to be made available for people with diabetic macular oedema (DMO) after the National Institute for Health and Clinical Excellence (NICE) turned down an appeal for it to be used on the NHS.
Diabetes UK, JDRF, the Macular Disease Society (MDS) and the Royal National Institute of Blind People (RNIB) are urging the manufacturer of Lucentis, Novartis, to rapidly agree a Patient Access Scheme with the Department of Health and NICE in order to reduce the cost of this treatment to the NHS and ensure the maximum number of people with DMO can benefit from the treatment without delay.
50,000 people
At least 50,000 people in the UK are affected by DMO [1], a serious eye condition which can lead to sight loss as a result of fluid leaking from the small blood vessels in the eye. Traditionally, laser treatment has been the standard treatment for DMO on the NHS, yet this only stops vision from deteriorating further. Lucentis, given in the form of an injection in the eye, however, is the first licensed treatment to improve vision in people with sight loss due to DMO.
NICE announced its original decision not to recommend Lucentis as a treatment for people with DMO on the NHS in July on the basis of cost-effectiveness. The charities appealed this decision, arguing that NICE failed to act fairly as key patient organisations and clinicians were not given the opportunity to comment on significant new evidence submitted by the drug manufacturer which may have led to incorrect conclusions being drawn in NICE's final decision.
Rejected
Now that the appeals have been rejected, the charities are calling on Novartis, the Department of Health and NICE to quickly agree a patient access scheme to ensure patients are able to access the treatment.
NICE has also made clear that people who are already receiving treatment on the NHS with Lucentis should have the option to continue treatment until they and their clinician consider it appropriate to stop.
Diabetes UK
Simon O'Neill, Director of Care, Information and Advocacy at Diabetes UK, said: "Naturally we are disappointed that NICE has turned down our appeal as we believe this treatment is vital to prevent people from needlessly losing their sight. Diabetic retinopathy is the leading causes of blindness in people of working age in the UK and the human impact of this stretches far beyond the financial costs.
"It is now of utmost importance that the drug manufacturer works with the Department of Health and NICE to negotiate the costs of this treatment so people with diabetes are still able to access it without detracting from other vital NHS services, such as Diabetes Specialist Nurses and eye screening."
JDRF
Sarah Johnson, Director of Policy and Communications at JDRF said: "Our concern is that NICEs' decision to turn down our joint appeal will directly impact thousands of people with Type 1 diabetes. People with the condition have a right to access safe and effective treatments to protect them from the serious complications of their condition, one of which is Diabetic Macular Oedema. We supported research into Lucentis during the early stages of the drug's development, and were disappointed by NICE's decision not to recommend the drug for use on the NHS. It is now vital that the Department of Health and NICE work together with the drug manufacturer to ensure the best outcome for people at risk of losing their sight."
The Macular Disease Society
Helen Jackman, CEO the Macular Disease Society, said: "We are disappointed because this treatment makes such a difference to the lives of people with sight loss caused by diabetes. We do urge the manufacturer and the department of health to find a solution - it is not acceptable just to deny people access to a treatment that works."
RNIB
Steve Winyard, RNIB Head of Policy and Campaigns said: "As a patient organisation, we are deeply frustrated that a full review of all the available information has not been allowed. Patients at risk of losing their sight have a right to expect that clinical experts and patient organisations have a chance to review all the evidence on a treatment. We firmly believe that some of the assumptions made about the cost-effectiveness of the treatment were wrong. In particular, there is a very strong case for providing Lucentis to those patients with thicker retinas who are unable to benefit from existing laser treatments. A second consultation would have allowed this to be examined. However, we now hope that a patient access scheme can be agreed swiftly, so that patients with DMO are not left to needlessly lose their sight."
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For further media information please contact RNIB PR Team on 020 7391 2223 or email pressoffice@rnib.org.uk
Notes to editors:
1 Aberdeen Health Technology Assessment Group (2011) Evidence Review: Ranibizumab for the treatment of diabetic
macular oedema. Available on NICE's website (PDF version)
2 Type 1 diabetes develops when insulin-producing cells in the pancreas are destroyed. This type of diabetes usually appears before the age of 40 and accounts for around 10 per cent of all people with diabetes. Type 1 diabetes cannot be prevented, it is not known why it develops and it is not connected with being overweight. People with Type 1 diabetes have to take insulin either via a pump or by injections several times a day to stay alive. Type 2 diabetes develops when the body can still make some insulin, but not enough, or when the insulin that is produced does not work properly. Insulin acts as a key unlocking the cells, so if there is not enough insulin, or it is not working properly, the cells are only partially unlocked (or not at all) and glucose builds up in the blood. Type 2 diabetes usually affects people over 40 (over 25 in people from South Asian and Black backgrounds) and can be treated with a healthy diet and increased physical activity but medication and/or insulin is often required. In around 80 per cent of cases the condition is linked with being overweight and can go undetected for up to ten years.
3 Diabetes UK is the leading charity for over 3.5 million people in the UK with diabetes. In 2011, Diabetes UK aims to spend over £6 million on diabetes research to investigate the causes and prevention of diabetes, to improve care and treatment of diabetes and ultimately to work towards a cure. For more information visit www.diabetes.org.uk. In the UK, there are currently 2.9 million people diagnosed with diabetes and it is estimated that 850,000 people have Type 2 diabetes but do not know it.
4 JDRF exists to find the cure for type 1 diabetes and its complications, and is the world's leading charitable funder of type 1 diabetes research. At a global level JDRF volunteers and staff have been responsible for raising over £850 million to support type 1 diabetes research since the charity's inception. www.jdrf.org.uk
5 The Macular Disease Society is the largest patient member organisation in the visual impairment sector and the only one which specialises in supporting people with macular disease. The Society has more than 230 local support groups across the UK and offers a range of free information, advice and counselling services. It also campaigns for better care for people with macular disease and funds research into treatments and improvements in quality of life.
6 About RNIB: Every day around 100 people in the UK start to lose their sight. There are around 2 million people in the UK with sight problems. RNIB is the leading charity working in the UK offering practical support, advice and information for anyone with sight difficulties. If you, or someone you know, has a sight problem RNIB can help. Call the RNIB Helpline on 0303 123 9999 or visit www.rnib.org